Cancer Institute A national cancer institute
designated cancer center

Tze Leung Lai

Publication Details

  • Sequential design of phase II-III cancer trials STATISTICS IN MEDICINE Lai, T. L., Lavori, P. W., Shih, M. 2012; 31 (18): 1944-1960


    Although traditional phase II cancer trials are usually single arm, with tumor response as endpoint, and phase III trials are randomized and incorporate interim analyses with progression-free survival or other failure time as endpoint, this paper proposes a new approach that seamlessly expands a randomized phase II study of response rate into a randomized phase III study of time to failure. This approach is based on advances in group sequential designs and joint modeling of the response rate and time to event. The joint modeling is reflected in the primary and secondary objectives of the trial, and the sequential design allows the trial to adapt to increase in information on response and survival patterns during the course of the trial and to stop early either for conclusive evidence on efficacy of the experimental treatment or for the futility in continuing the trial to demonstrate it, on the basis of the data collected so far.

    View details for DOI 10.1002/sim.5346

    View details for Web of Science ID 000306471100004

    View details for PubMedID 22422502

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